Overview

A Different Approach to Preventing Thrombosis

Status:
Completed
Trial end date:
2017-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to perform a pragmatic randomized controlled trial to compare the use of low molecular weight heparin (LMWH, lovenox, enoxaparin) versus acetylsalicylic acid (ASA) for venous thromboembolism (VTE) prophylaxis in patients with high-risk lower extremity fractures.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Maryland
University of Maryland, Baltimore
Treatments:
Aspirin
Dalteparin
Enoxaparin
Heparin
Heparin, Low-Molecular-Weight
Tinzaparin
Criteria
Inclusion Criteria:

- All patients treated at a level-1 trauma center with any one or more of the following
injuries: Pelvis fracture (operative or non-operative), Acetabulum fracture (operative
or non-operative), or any operative extremity fracture (proximal to
metatarsals/carpals)

- Age greater than or equal to 18 years old

Exclusion Criteria:

- Patients receiving pre-existing confounding prophylaxis or therapeutic anticoagulation
(not to include anti-platelet agents) prior to admission or those receiving greater
than one dose of LMWH since injury

- Patients with pre-existing coagulopathy

- Patients with a previous history of VTE within the last 6 months

- Patients who are pregnant

- Patients with CNS or spinal cord injury with potential need for further neurosurgical
intervention precluding anticoagulation with aspirin

- Patients with active bleeding precluding the use of anticoagulation

- Impaired creatinine clearance <30ml/min at the time of randomization

- History of Heparin Induced Thrombocytopenia or ASA or NSAID allergy

- Prisoners

- Non-english speaking patients

- Patients who have an indication for therapeutic anticoagulation

- Patients deemed inappropriate for inclusion in the study by their treating physician.
Reason must be documented

- Patients who would not normally receive VTE prophylaxis for their injury